MCW Human Research Protections Certification Program

 

Introduction  Requirements  FAQ  How Do I...  Contact

To Login/Access CITI online program: https://www.citiprogram.org
 

Introduction 

Welcome to the MCW Human Research Protections Certification Program.  In 2004 MCW announced the requirement to all individuals involved in the design, conduct or review of human subjects research to have been certified under a new educational program. 2004 Certification Letter

The program requirements include reading the Belmont Report and key MCW research documents and policies, completing the required modules of the Collaborative IRB Training Initiative (CITI) Program, maintaining CITI certification and additional annual educational requirements. The purpose of certification is threefold:

  1. Responsible Conduct in Research - to assure a thorough and universal foundation in the ethical and legal principles guiding human participant research.
  2. Scientific Integrity - to enhance the awareness of, and sensitivity to research integrity issues such as conflict of interest.
  3. Public Duty - to demonstrate to our study volunteers, the community, and research sponsors that we have the training and expertise necessary to protect the rights and welfare of research participants.

The CITI Program website content is offered in English, French, Japanese, Korean, Portugese, Russian, and in Spanish.  The Medical College of Wisconsin has created Learner Groups 9 and 10 for Spanish Language Biomedical researchers and Spanish Language Social and Behavioral researchers.

[back to top]

Requirements

Initial
Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must obtain CITI certification.  CITI certification is obtained by completing the required on-line modules with an overall score of 80%.  The initial CITI course can be completed in four to six hours.  Six CE credits are available from CITI.

  • New employees must complete the required modules and obtain CITI certification within 90 days from date of hire.
  • Members of the human subject research team, including the Principal Investigator (PI), must have current certification. 

The required modules depend on the type of research and your role in that research.

  • Biomedical Research involves any type of clinical research studies, including those that involve investigational drugs and/or devices. 
  • Social/Behavioral Research involves observational and survey research, work with population and/or epidemiological studies. This type of research does not involve any drugs or devices (investigational or marketed).

 

Research Role Biomedical Research Behavioral & Social Research
PI or Co-Investigator Learner Group 1 Modules Learner Group 4 Modules
Study Coordinator Learner Group 1 Modules Learner Group 4 Modules
Other Research Staff Learner Group 2 Modules Learner Group 5 Modules
Community Research partner not in role as PI or Study Coordinator Learner Group 6 Modules Learner Group 6 Modules
Staff Nurse Learner Group 8 Modules Learner Group 8 Modules
Member of IRB or other human subject research review committee, IRB Staff Learner Group 3 Modules Learner Group 3 Modules

Ongoing
Annual

Additional human subject protection education is required each year for investigators and coordinators.

  • MCW investigators and coordinators must obtain three hours of human subject protection education annually.
  • Non MCW members of the research team must obtain one hour of human subject protection education annually.

CITI Refresher
In order to maintain CITI certification, everyone is required to complete the CITI Refresher course every three (3) years after initial certification is obtained.  Completion of the refresher modules can usually be completed in less than two hours. 

[back to top]

FAQs

Who must complete requirements of the MCW Human Research Protections Certification Program?
Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must be certified.

What modules must I complete?
The required modules depend on the type of research and your role in that research.

  • Biomedical Research involves any type of clinical research studies, including those that involve investigational drugs and/or devices. 
  • Social/Behavioral Research involves observational and survey research, work with population and/or epidemiological studies. This type of research does not involve any drugs or devices (investigational or marketed).

 

Type of Research Biomedical Research Behavioral & Social Research
PI or Co-Investigator Learner Group 1 Modules Learner Group 4 Modules
Study Coordinator Learner Group 1 Modules Learner Group 4 Modules
Other Research Staff Learner Group 2 Modules Learner Group 5 Modules
Community Research partner not in role as PI or Study Coordinator Learner Group 6 Modules Learner Group 6 Modules
Staff Nurse Learner Group 8 Modules Learner Group 8 Modules
Member of IRB or other human subject research review committee, IRB Staff Learner Group 3 Modules Learner Group 3 Modules

[back to top]

 How do I....?

What do I need to do?

  1. Register at www.citiprogram.org (Internet Explorer - recommended).
  2. Follow the instructions for CITI sign-on, and completion of course modules.        
  3. Print “Completion Report” and keep for your records.

What do I do if I forgot my user name or password?
If you have forgotten your user name and/or password, click on “Forgot username or password?” link on the CITI Program homepage and follow instructions.  

How do I register, create my CITI Program account, and select my Learning Group Modules?

  1. Go to www.citiprogram.org and click on the "Register" button located on the right-hand side of the page.
  2. Step 1: enter "Medical College of Wisconsin" as your organization and click on "Continue"
  3. Step 2: enter your first and last name and email address and click on "Continue".  (Recommendation - list your first and last name and email address as listed in your eBridge account and consider including a secondary email address)
  4. Step 3: Choose a username and password for your CITI account following the instructions for each field; you must also select and answer a security question and click on "Continue".
  5. Step 4: Provide information regarding gender, ethnicity and race and click on "Continue".
  6. Step 5: Provide information regarding CE credits and completion of surveys and click on "Continue".  CE credits are available for purchasing by the individual.
  7. Step 6: Provide the required information for the Medical College of Wisconsin as identified by the *.
  8. Select the Learner Group that most closely matches your research and your role in research; choose from Learner Groups 1-6, or 8 and click on "Next".  

How do I access/complete the CITI modules?

  1. Go to www.citiprogram.org.
  2. Enter username and password used to register with CITI Program.
  3. On the Main Menu page, click on the course title to begin or continue the coursework.
  4. Complete the Integrity Assurance Statement.
  5. Complete the required modules and associated quizzes.  You may re-review the modules and repeat any quizzes to attain the overall passing score of 80%. (Once you have completed all of the required modules in your curriculum you will be shown optional modules which may be completed at a future time).
  6. Upon successful completion of the modules and associated quizzes print a copy of your completion report for your records.  

How do I add MCW/change my affiliated institution or transfer my completions?

  1. Go to www.citiprogram.org.
  2. Enter username & password used to register with CITI at previous or other institution.
  3. On the Main Menu page, click on "My Profiles" to edit or change your email address as needed. 
  4. On the Main Menu page, click on the link  “Affiliate with Another Institution”.  Enter "Medical College of Wisconsin" (MCW) as your organization and click on "Next".
  5. Provide the requested information for MCW's registration questions. 
  6. Enroll in the course - human subject research and select the Learner Group that most closely matches your role and type of research (Group 1 – 6 or 8)
  7. On the Main Menu page in the section "My Learner Tools for Medical College of Wisconsin" Click "View Previously Completed Coursework" and verify previous CITI completed modules are displayed.  (To receive credit for modules previously completed you must be affiliated with both institutions;  enroll in the course that needs to be transferred via "Add a Course or Update Learner Groups' link for MCW and select the applicable Learner Group.  Once you are enrolled in the course, any modules that are shared between the institutions will have their credit transferred automatically.  The transfer is based upon the module's unique ID number.  Each institution determines the timeframe in which modules are transferable, some institutions do not allow modules to transfer. )
  8. On the Main Menu page you will see the selected Learner Group for MCW and status of "Not Started" or "Incomplete".
  9. Click on the Learner Group to see the list of the required modules for MCW; complete the incomplete modules and associated quizzes. 

Please note: Institutions choose from a wide variety of modules and overlap with MCW modules will vary. All modules required for MCW certification must be completed.

How do I remove my affiliation from an institution?

  1. Go to www.citiprogram.org.
  2. Enter username & password.
  3. Click on "Remove Affiliation" found in the section "My Learner Tools for Medical College of Wisconsin".
  4. Removing your affiliation will also remove access to completion report records for this institution.

How do I update my name and/or email address?

  1. Go to www.citiprogram.org.
  2. Enter username & password.
  3. Click on "My Profiles" then click on the applicable link ("Change my name", "Change my email address").
  4. Enter the updated information click on "Update".

How do I change learner groups on CITI?

  1. Go to www.citiprogram.org
  2. Enter username & password
  3. On the Main Menu page your current Learner Group is listed under Course.  To change your learner group click on “Add a Course or Update Learner Groups" located in the section "My Learner Tools for Medical College of Wisconsin".
  4. Select the Learner Group that most closely matches your role and type of research (Group 1 – 6, or 8) and click on "Next".
  5. Indicate whether you will be completing the initial course or refresher course for that Learner Group and click on "Submit".
  6. On the Main Menu page Under “Course” you should see a the status for the course (Not Started or Incomplete)
  7. Click on the Course link and begin course work for modules which still require to be completed for the new Learner Group which was selected.
  8. On the Main Menu page in the section "My Learner Tools for Medical College of Wisconsin" click "View Previously Completed Coursework" and verify previous CITI completed modules are displayed.

Will my training that I completed at another institution be accepted?
If you are involved in human subject research at either Children’s Hospital of Wisconsin, or the Zablocki Veterans Administration Medical Center and are current in your human subject protection training, MCW will accept this training.

If you have completed human subject protection training at an institution other than Children’s Hospital of Wisconsin or the Zablocki Veterans Administration Medical Center and request MCW acceptance of the training, please contact _citihelpdesk@mcw.edu .

How long will it take to complete the certification program?
The total time is approximately 4 to 6 hours for the basic course and less than 2 hours for the refresher course.  You may complete it multiple sittings.  The certification program is web-based and can be accessed from any computer via the internet.

Why can I not see information regarding my completed CITI Program Modules in eBridge?

  1. The recorded first and last name in the CITI Program and eBridge accounts are not the identical.  To correct this, update your CITI Program account information to reflect your name as documented in eBridge; see "How do I update my name/email address?" for further instruction.
  2. The email address listed in eBridge differs from the preferred email address listed with CITI Program.   To correct this, update your CITI Program account information to reflect your email address as documented in eBridge; see "How do I update my name/email address?" for further instruction.
  3. There is more than one CITI Program account associated with an individual's name.  To correct this please contact _citihelpdesk@mcw.edu and request that your accounts be merged.
  4. You have not completed the affiliation of CITI Program training with the Medical College of Wisconsin.  To correct this, please complete the process as described in "How do I add MCW/change my affiliated institution or transfer my completions?".

What are some available options for the required annual education/training?

  • Annual Research Conference
  • MCW program, clinical research workshop or seminar regarding human research
  • Human Research Professionals Meeting
  • CITI Core Course module not done for initial certification CITI Refresher Course module not required for biennial recertification
  • Clinical Research Scholars Program
  • Non-MCW sponsored courses regarding human subject research
  • NIH computer based training

[back to top]

 

Contact

Whom should I contact if I have questions about logging on, updating institution or learner information, or I am visually impaired?
   Please contact _citihelpdesk@mcw.edu .

 


[back to top]

Medical College of Wisconsin
8701 Watertown Plank Road
Milwaukee, WI 53226
(414) 955-8296
Directions & Maps
© 2014

Top